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NCT00172133 · ClinicalTrials.gov registry record · Phase 3
Open Label Extension Study of PREOS
A Phase 3 study of Osteoporosis, sponsored by Shire.
- Completed
- Registry status
- Phase 3
- Development phase
- 1,683
- Enrollment target
- 20
- Study locations
NCT00172133: Completed Phase 3 study of Osteoporosis, sponsored by Shire.
NCT00172133 is a Phase 3 study of Osteoporosis that has completed, run by Shire. The registered enrollment target is 1,683 participants, above the 1,526-participant average among 84 other Osteoporosis trials with a reported enrollment target (10% higher). The trial reports 20 study locations across 6 states. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT00172133, a Phase 3 study of Osteoporosis, has completed, sponsored by Shire.
- COMPLETED
- Registry status
- Phase 3
- Development phase
- 1,683 participants
- Enrollment target
- 20
- Study locations
Study Summary
This is an Open Label Extension Study (OLES) for patients who participated in the 18 month double-blind, placebo-controlled, Phase III trial (Protocol ALX1 11 93001 the TOP Study) studying the effect of ALX1-11, recombinant human parathyroid hormone, rhPTH(1-84), on vertebral fracture incidence. The primary objective of this study is to evaluate the safety of continued dosing with ALX1-11, up to a maximum of 24 months, in postmenopausal osteoporotic women who participated in Protocol ALX1 11 93001.
Conditions Studied
Interventions
- DRUG ALX1-11 (drug)
Study Locations (20)
California
- 'Osteoporosis Medical Center - Beverly Hills
- 'East Bay Clinical Trial Center - Concord
- 'Loma Linda Osteoporosis Research Center - Loma Linda
- Foundation for Osteoporosis Research - Oakland
- 'Desert Medical Advances - Palm Desert
- 'VA Palo Alto Health Care System - Palo Alto
- 'Boling Clinical Trials - Rancho Cucamonga
- 'S.D. Arthritis & Osteoporosis Medical Clinic - San Diego
- 'Radiant Research - San Diego - San Diego
- 'San Francisco General Hospital - San Francisco
Florida
- 'RASF - Clinical Research Center - Boca Raton
- 'The Center for Diabetes and Endocrine Care - Hollywood
- 'Florida Wellcare Alliance - Inverness
- 'Renstar Medical Group - Ocala
- 'The Arthritis Center - Palm Harbor
Alabama
- 'The University of Alabama at Birmingham - Birmingham
- 'Rheumatology Associates of North Alabama - Huntsville
Arizona
- 'Radiant Research - Phoenix North - Phoenix
Colorado
- 'Longmont Medical Research Network - Longmont
Connecticut
- 'Northeast Clinical Research, LLC - Hamden
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 1,683 participants |
| Start Date | 2001-10-16 |
| Est. Completion | 2005-04-13 |
| Phase | Phase 3 |
What the finished NCT00172133 record still lists
NCT00172133 is an interventional study that assigns participants to a tested intervention. Its 1,683 participants enrollment target places it among the larger protocols in the corpus, above the 1,526-participant average among 84 other Osteoporosis trials with a reported enrollment target (10% higher).
The record links to 1 condition, with Osteoporosis appearing as the primary indexed condition, and to 1 intervention - of which ALX1-11 (drug) is the first listed.
NCT00172133 names 20 study sites across 6 states, led by California, Florida, Alabama.
Frequently Asked Questions
What is clinical trial NCT00172133 about?
NCT00172133 is a clinical study titled "Open Label Extension Study of PREOS". This is an Open Label Extension Study (OLES) for patients who participated in the 18 month double-blind, placebo-controlled, Phase III trial (Protocol ALX1 11 93001 the TOP Study) studying the effect of ALX1-11, recombinant human parathyroid hormone, rhPTH(1-84), on vertebral fracture incidence. The...
What is the current status of trial NCT00172133?
This trial is currently completed. It is a Phase 3 study. The enrollment target is 1,683 participants. The study started on 2001-10-16. Estimated completion is 2005-04-13.
What conditions does trial NCT00172133 study?
This clinical trial studies the following conditions: Osteoporosis.
What interventions are being tested in trial NCT00172133?
The interventions under investigation include: ALX1-11 (drug) (DRUG).
Who is sponsoring clinical trial NCT00172133?
This trial is sponsored by Shire, which has 245 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT00172133 being conducted?
This trial has 20 study locations across Alabama, Arizona, California, Colorado, Connecticut. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
Learn More About Clinical Trials
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Where NCT00172133's enrollment target sits among peer trials
1,683 11th of 84 higher than 74 of 84 other Osteoporosis trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Osteoporosis trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
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